Fortrea is a leading global contract research organization (CRO) specializing in clinical trials and drug development. With a mission to advance life-saving therapies, Fortrea supports pharmaceutical and biotech companies in delivering high-quality clinical research.
Detailed Job Description: TMF Reviewer I
Job Overview
The TMF Reviewer I ensures compliance with regulatory standards (GCP/ICH) by managing electronic Trial Master Files (eTMF) for clinical studies. This role involves document classification, quality checks, and audit readiness.
Key Responsibilities
✔ Perform TMF review of clinical trial documents (Trial, Country, Site levels)
✔ Ensure audit readiness by verifying document accuracy and compliance
✔ Collaborate with study teams for regulatory document management
✔ Support internal/client audits and corrective actions
✔ Maintain eTMF systems (e.g., Workday, Adobe Acrobat, sponsor-specific platforms)
✔ Train and mentor junior team members
Work Environment
📍 Location: Bangalore (Hybrid/Remote options if applicable)
⏰ Job Type: Full-time
📅 Application Deadline: July 5, 2025
Eligibility & Qualifications
Minimum Requirements
✅ Education: Bachelor’s degree in Life Sciences/Business
✅ Experience: 4-8 years in clinical research (GCP/ICH knowledge)
✅ Technical Skills: MS Office, Adobe Acrobat, eTMF systems
Preferred Qualifications
🎓 Master’s degree in Life Sciences
💼 6-10 years of clinical research experience
💻 Experience with clinical electronic systems
Benefits & Perks
✔ Competitive salary & performance bonuses
✔ Health & wellness programs
✔ Career growth in a global CRO
✔ Flexible work policies (if applicable)
✔ Training & mentorship programs
How to Apply
